Study Evaluating the Effects of Multiple Oral Doses of ERB-041 on Cardiac Repolarization in Healthy Subjects

Completed · Phase 1

Conditions studied: Healthy, Long QT Syndrome

In brief

To assess the effect of ERB-041 after multiple oral doses on cardiac repolarization as assessed by the QTc interval.

Key facts

Study ID

NCT00316459

Run by

Wyeth is now a wholly owned subsidiary of Pfizer

People needed

64

Starts

2006-05-01

Last updated by the study team

2007-04-13

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and ECG.
• Nonsmoker or smoker of fewer than 10 cigarettes (half a pack) per day as determined by history.

You may not qualify if…

• A family history of long QT syndrome and/or cardiac death.
• Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematological, neurological, or psychiatric disease.

Where it is running

• Study site — Miami, Florida, United States

Full record on ClinicalTrials.gov

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